Effect of COVID-19 on Platelet Aggregation

NCT04447131 | Completed

• 1 other identifier: SDC 5089/20/118
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

This is a mechanistic, observational, prospective, case and control study, to compare platelet aggregation, analyzed by Multiplate-ADP, in hospitalized patients diagnosed with COVID-19 versus healthy controls. Thus will be included 60 patients who present with respiratory symptoms within 72 hours of hospitalization and confirmation of the diagnosis of COVID-19 by laboratory method (RT -PCR and / or positive serology for SARS-CoV-2 - COVID group); this group will be compared to 60 healthy individuals (asymptomatic and with negative SARS-CoV-2 serology), matched by sex and age to the previous group.

Conditions

COVID-19; SARS-CoV-2

Keywords

Platelet aggreggation; COVID-19; SARS-CoV-2; Multiplate

Outcome Measures

Primary Outcomes (1)

• Platelet aggregation analyzed by Multiplate-ADP

  Compare platelet aggregation analyzed by Multiplate-ADP in hospitalized patients diagnosed with COVID-19 versus healthy controls.

  at inclusion

Secondary Outcomes (10)

• Platelet aggregation by Multiplate-ASPI and Multiplate-TRAP in patients hospitalized for COVID-19 versus healthy controls.

  at inclusion

• Reticulated platelet fraction in patients hospitalized for COVID-19 versus healthy controls.

  at inclusion

• Platelet aggregation for COVID-19 versus patients hospitalized for respiratory symptoms but negative for COVID-19.

  at inclusion,

• Reticulated platelet fraction in patients hospitalized for COVID-19 versus patients hospitalized for respiratory symptoms but negative for COVID-19 research.

  at inclusion

• Platelet aggregation in patients hospitalized for COVID-19 versus patients hospitalized for Influenza.

  at inclusion

Study Arms (3)

COVID-19

Confirmation of the diagnosis of COVID-19 by laboratory method (RT-PCR and / or positive serology for SARS-CoV-2 - COVID group).

Other: venipuncture in peripheral vein

Healthy Individuals

Asymptomatic and with negative SARS-CoV-2 serology

Other: venipuncture in peripheral vein

Respiratory symptoms but negative for COVID-19

Negative for SARS-CoV-2. But with respiratory symptoms

Other: venipuncture in peripheral vein

Interventions

venipuncture in peripheral vein OTHER

single vacuum venipuncture in peripheral vein

COVID-19; Healthy Individuals; Respiratory symptoms but negative for COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with up to 72 hours of hospitalization for respiratory symptoms, tested with RT- PCR for respiratory viruses, will be evaluated for inclusion. Patients with diagnostic criteria for COVID-19 will be considered a case group (COVID-19 group) and will be compared to two other groups: patients hospitalized for respiratory symptoms with a negative test for SARS-CoV-2, and healthy control group.

You may qualify if:

• Agreement to sign the Free and Informed Consent Form (ICF).
• Case group: patients with up to 72 hours of hospitalization for respiratory symptoms.
• Control group: healthy volunteers, defined as having no history (confirmed or suspected) of COVID-19 or chronic diseases (except hypertension, obesity, dyslipidemia)

You may not qualify if:

• Known platelet dysfunction or platelet count \<100,000 / µL or\> 450,000 / µL;
• Terminal illness;
• Known liver disease or clotting disorder;
• Hematocrit less than 34% or greater than 55%;
• Previous use of antiplatelet agents and / or anticoagulants (except acetylsalicylic acid and prophylactic heparin);
• Patients on invasive mechanical ventilation or receiving high oxygen flow.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (2)

Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo

São Paulo, 05403-900, Brazil

Location

Instituto de infectologia Emílio Ribas

São Paulo, Brazil

Location

Related Publications (12)

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  PMID: 20113977 BACKGROUND

• Rondina MT, Brewster B, Grissom CK, Zimmerman GA, Kastendieck DH, Harris ES, Weyrich AS. In vivo platelet activation in critically ill patients with primary 2009 influenza A(H1N1). Chest. 2012 Jun;141(6):1490-1495. doi: 10.1378/chest.11-2860. Epub 2012 Mar 1.

  PMID: 22383669 BACKGROUND

• Le VB, Schneider JG, Boergeling Y, Berri F, Ducatez M, Guerin JL, Adrian I, Errazuriz-Cerda E, Frasquilho S, Antunes L, Lina B, Bordet JC, Jandrot-Perrus M, Ludwig S, Riteau B. Platelet activation and aggregation promote lung inflammation and influenza virus pathogenesis. Am J Respir Crit Care Med. 2015 Apr 1;191(7):804-19. doi: 10.1164/rccm.201406-1031OC.

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• Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

  PMID: 32171076 BACKGROUND

• Zheng YY, Ma YT, Zhang JY, Xie X. COVID-19 and the cardiovascular system. Nat Rev Cardiol. 2020 May;17(5):259-260. doi: 10.1038/s41569-020-0360-5.

  PMID: 32139904 BACKGROUND

• Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

  PMID: 32031570 BACKGROUND

• Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70. doi: 10.7326/0003-4819-130-6-199903160-00002.

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• Rubak P, Villadsen K, Hvas AM. Reference intervals for platelet aggregation assessed by multiple electrode platelet aggregometry. Thromb Res. 2012 Sep;130(3):420-3. doi: 10.1016/j.thromres.2012.06.017. Epub 2012 Jul 17.

  PMID: 22809844 BACKGROUND

• Bertolin AJ, Dalcoquio TF, Salsoso R, de M Furtado RH, Kalil-Filho R, Hajjar LA, Siciliano RF, Kallas EG, Baracioli LM, Lima FG, Giraldez RR, Cavalheiro-Filho C, Vieira A, Strunz CMC, Giugliano RP, Tantry US, Gurbel PA, Nicolau JC. Platelet Reactivity and Coagulation Markers in Patients with COVID-19. Adv Ther. 2021 Jul;38(7):3911-3923. doi: 10.1007/s12325-021-01803-w. Epub 2021 Jun 4.

  PMID: 34086266 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Coronary Care Unit

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 25, 2020
• Study Start: April 29, 2020
• Primary Completion: June 30, 2020
• Study Completion: November 27, 2023
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)